European Commission grants EU marketing authorisation for aflibercept (Eylea) 8 mg

The marketing authorisation follows approval of aflibercept 2 mg in the EU. Image credit: ©Artjazz – stock.adobe.com

On Monday, the European Commission granted marketing authorisation for aflibercept (Eylea) 8mg. Bayer AG, based in Berlin, Germany, announced the approval in a press release.¹ In November 2023, the European Medicines Agency recommended approval of aflibercept 8 mg to the European Commission.² The approval follows prior approval of aflibercept 2 mg in the European Union. The injection has been assessed for treatment of two retinal diseases: neovascular age-related macular degeneration (nAMD) and diabetic macular oedema (DME).

Approval was recommended based on results from the PULSAR and PHOTON randomised, double-masked, active-controlled pivotal trials. The data from these trials indicated an extended period between dosing with 8 mg aflibercept, compared to 2 mg aflibercept, could significantly lower patient burden. Jean-François Korobelnik, Professor of Ophthalmology and Head of the Department of Ophthalmology at University Hospital of Bordeaux in France and a trial investigator, spoke to these results in Bayer’s press release about the aflibercept 8 mg approval.¹

“Eylea 8 mg is an important advancement in retinal care as it provides greater and longer lasting control of the disease. Doctors may extend their patients interval to 4 months, right after 3 initial monthly doses, based on their judgment,” Prof Korobelnik said. “This then does not only mean less eye injections and doctor visits for patients but could also help to mitigate capacity constraints faced in clinical practices in Europe.”

Following the PULSAR trial (in nAMD) and PHOTON trial (in DME), the safety profile of aflibercept 8 mg was declared to be consistent with that of the more-established aflibercept 2 mg. Aflibercept 8 mg is approved for administration at extended treatment intervals of up to every 4 months (following 3 initial monthly doses). Treatment intervals of up to 5 months may also be considered for patients who demonstrate stable visual outcomes.

Dr Michael Devoy, Chief Medical Officer of Bayer’s Pharmaceuticals Division, called the approval a “significant milestone in addressing the high unmet need to reduce the patients’ burden of retinal disease.” In a news release,¹ Dr Devoy stated, “Building on the standard of care therapy Eylea 2 mg, patients have now the opportunity to benefit from Eylea 8 mg with less frequent injections with comparable efficacy and safety to Eylea 2 mg.”

In the United States, ​​Aflibercept 8 mg was approved under the brand name Eylea HD by the Food and Drug Administration in August 2023. Aflibercept 8 mg is being jointly developed by Bayer and Regeneron, with Bayer, based in Berlin, Germany, maintaining exclusive marketing rights outside the United States. Bayer is awaiting regulatory decisions for aflibercept 8 mg in additional markets.

References

1. New Eylea™ 8 mg approved in EU. News release. Bayer AG. Published January 8, 2024. https://www.bayer.com/media/en-us/new-eylea-8-mg-approved-in-eu/#:~:text=Berlin%2C%20January%208%2C%202024%20%E2%80%93,nAMD)%20and%20visual%20impairment%20due

2. Hayes H. EMA recommends approval of high-dose intravitreal aflibercept (Eylea) 8mg for nAMD and macular oedema. Ophthalmology Times Europe. Published November 13, 2023. Accessed January 8, 2024. https://europe.ophthalmologytimes.com/view/ema-recommends-approval-of-high-dose-intravitreal-aflibercept-eylea-8mg-for-namd-and-macular-oedema